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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 28/01/2011
SPC Meningitec suspension for injection in a pre-filled syringe

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 28/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to marketing authorisation holder
  • Change to MA holder contact details
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
The update includes the MAH name and address change for the change of ownership from Wyeth to Pfizer
Updated on 01/03/2010 and displayed until 28/01/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   25-Jan-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 5.1 – Removal of
Serological correlates for protection have not been definitively established for conjugated meningococcal C vaccines; these are under study.

Section 5.1 – Removal of
Estimates of effectiveness based on a small number of cases to date indicate that there may also be waning protection in children who received a single priming dose as toddlers. Effectiveness in all other age groups (up to 18 years) primed with a single dose has so far remained around 90% or more within and more than one year after vaccination.

Section 5.1 – Addition of
Up to 2007 the overall estimates of effectiveness in age cohorts from 1-18 years that received a single dose of meningococcal group C conjugate vaccine during the initial catch-up vaccination programme in the UK fall between 83 and 100%. The data show no significant fall in effectiveness within these age cohorts when comparing time periods less than a year or one year or more since immunisation.
Updated on 03/02/2010 and displayed until 01/03/2010
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 10 - Date of revision of the text
Date of revision of text on the SPC:   12-Dec-2008
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.2: removal of
The vaccine must not be administered intradermally, subcutaneously or intravenously (see section 4.4).

Section 4.2 – Addition of
The vaccine must not be administered intravenously (see section 4.4). The safety and immunogenicity of administration via the intradermal or subcutaneous routes have not been evaluated.

Section 4.5 – removal of
Data on concomitant administration of Meningitec with 7-valent pneumococcal conjugate vaccine (Prevenar) are not available. However, data from an investigational combination vaccine (9-valent pneumococcal-CRM197 protein conjugate vaccine and meningococcal serogroup C-CRM197 protein conjugate vaccine [9vPnC-MnCC]) containing amongst others the same 7 conjugated pneumococcal serotypes as Prevenar have shown that meningococcal serogroup C (MnC) serum bactericidal antibodies (SBA) titres were lower in recipients of this combination than those receiving Meningitec alone, although almost all subjects achieved a titre of at least 1:8.

One study using a 2, 3 and 4 month schedule showed that 75% and 79% of vaccinees in two groups that received Meningitec alone for the primary series still had SBA titres of at least 1:8 at 12 months of age compared to only 28% and 31% in the two groups primed with the 9vPnC-MnCC vaccine. One month following the twelve-month booster dose, 100% of the MnCC group and 100% of the 9vPnC-MnCC group had SBA titres of at least 1:8.

The potential for immune interference in the antibody response between Prevenar and Meningitec should be taken into consideration before concomitant administration of these vaccines as a 2, 3, and 4 month or another primary series schedule. Consideration should also be given to the age at which the booster dose is administered following priming with concomitant Meningitec and Prevenar.

Section 4.5 – Addition of
In a clinical trial that compared separate with concomitant administrations of Meningitec (two doses at 2 and 6 months and a booster dose at approximately 12 months) and Prevenar (pneumococcal conjugate 7-valent vaccine; three doses at 2, 3.5, 6 months and a booster dose at approximately 12 months) there was no evidence of immune interference between the two conjugate vaccines after the primary series or after the booster doses.

Section 10
Date of revision updated


Updated on 01/12/2008 and displayed until 03/02/2010
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:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelf life increased to 2 years
Updated on 25/08/2008 and displayed until 01/12/2008
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
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4 - inclusion of warning on Apnoea

Section 4.8 - inclusion of Apnoea to undesirable effects

Section 5.1 – Change in the ATC code
Updated on 16/10/2007 and displayed until 25/08/2008
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Meningococcal group C conjugate vaccine