The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com
Need to contact this company?
Summary of Product Characteristics last updated on the eMC: 04/03/2010
SPC Pandemrix suspension and emulsion for emulsion for injection

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 04/03/2010 and displayed until Current
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 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.1 - To add the safety and immunogenicity data in children aged 3-9 years from two clinical studies (H1N1-010, H1N1-023) carried out in children aged from 3 to 17 years.

Section 4.8 - To add the safety and immunogenicity data in children aged 3-9 years from two clinical studies (H1N1-010, H1N1-023) carried out in children aged from 3 to 17 years.

Section 5.1 - To add the safety and immunogenicity data in children aged 3-9 years from two clinical studies (H1N1-010, H1N1-023) carried out in children aged from 3 to 17 years.

Section 10 -  New Date
Updated on 07/01/2010 and displayed until 04/03/2010
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • 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:   22-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 -Posology updated

Section 4.4 - Statement updated: "There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1) in children aged less than 6 months. There are limited data available from a clinical study with Pandemrix (H1N1) in healthy children aged from 10 to 17 years,"

Section 4.5 - Information on co-administration with Fluarix

Section 4.8-More information from clinical study added

Section 5.1 - Information on Adults aged 18-60 years updated and new section Children aged 10-17 years added

Section 10 - New revision date
Updated on 21/12/2009 and displayed until 07/01/2010
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 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Posology for Children aged from 6 months to 9 years updated

Section 4.4 -Added "Very limited data in children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses indicate an increase in the rates of injection site reactions and general symptoms (see section 4.8). In particular rates of fever (axillary temperature =38°C) may increase considerably after the second dose. Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each vaccination."

Section 4.8 -Adverse reactions for Children aged 3-9 years, Children aged 6-35 months and post-marketing surveillance updated.

Section 5.1 -Update information on children aged 6-35 months

Section 10 - New Date
Updated on 04/12/2009 and displayed until 21/12/2009
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Posology updated based on data from D-Pan H1N1-008 study (post dose 1 in >60 years old) and D-Pan H1N1-009 study (post dose 1 (half dose) in 6 months-3 years old children)

Section 4.4 - Added "There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1) in children and adolescents aged from 3-17 years or in children aged less than 6 months. There are very limited data available from a clinical study with Pandemrix (H1N1) in healthy children aged from 6 to 35 months and limited data from a study with a version of Pandemrix containing H5N1 antigens in children aged from 3 to 9 years.

There are limited data available from clinical studies with Pandemrix (H1N1) in adults aged over 60 years and very limited data with Pandemrix (H1N1) or with a version of the vaccine containing H5N1 antigens in adults aged over 80 years. "

 Section 4.5 - Added "Data obtained on co-administration of Pandemrix H1N1 with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix H1N1. The immune response to Fluarix was satisfactory.

Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone.

Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).

.

There are no data on co-administration of Pandemrix with other vaccines.

If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.Section 4.8 - Added new information based on data from D-Pan H1N1-008 study (post dose 1 in >60 years old), D-Pan H1N1-009 study (post dose 1 (half dose) in 6 months-3 years old children), and post-marketing surveillance data.

Section 5.1 - Added new information based on data from D-Pan H1N1-008 study (post dose 1 in >60 years old) and D-Pan H1N1-009 study (post dose 1 (half dose) in 6 months-3 years old children).

Section 6.6 - Clarification around instructions for mixing and administration of the vaccine

Section 10 - New date
Updated on 20/11/2009 and displayed until 04/12/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   11-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2-to reflect newly available results from a clinical study in adults 18-60 years of age (H1N1-007).
Section 4.5- to reflect newly available results from a clinical study in adults 18-60 years of age (H1N1-007).

Section 6.5-update the instructions for mixing and administration of the vaccine
Updated on 19/10/2009 and displayed until 20/11/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  influenza vaccine (split virion, inactivated)


Return to the top of the page

© 2010 Datapharm Communications Ltd

Go to www.medicines.org.uk