Summary of Product Characteristics
last updated on the eMC:
16/02/2012
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 16/02/2012 and displayed until Current
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 30-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 18/07/2011 and displayed until 16/02/2012
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 30-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7: MAH to Pfizer Limited from JW&B Limited
Section 8: new MA number (PL 00057/1302) to reflect new ownership
Section 9 & 10: approval date of new licence added.
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Updated on 26/02/2010 and displayed until 18/07/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 26-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 Posology and method of administration
[…]
The need for booster doses in subjects primed with a single dose (i.e. aged 12 months or more when first immunised) has not yet been established (see section 5.1).
Section 5.1 Pharmacodynamic properties
[…]
Immunogenicity
No prospective efficacy trials have been performed.
Serological correlates for protection have not been definitively established for conjugated meningococcal C vaccines; these are under study.
The serum bactericidal antibody (SBA) assay referenced in the text below, used rabbit serum as a source of complement.
[…]
Within one year of completion of the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% CIconfidence intervals: 67, 99). However, more than one year after completion of the primary series, there was clear evidence of waning protection. 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.
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 rangefall 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.
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Updated on 31/07/2009 and displayed until 26/02/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 6.5 the following text has been added.
and a multipack of 2 packs of 10 pre-filled syringes without needle.
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Updated on 03/07/2009 and displayed until 31/07/2009
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 22-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In Section 6.5 .................(latex-free gray butyl rubber) and a protective-tip cap (latex-free gray butyl rubber) has been added.
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Updated on 15/12/2008 and displayed until 03/07/2009
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 05-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - Text added:
Method of administration
Meningitec is for intramuscular injection, preferably in the anterolateral thigh in infants and in the deltoid region in older children, adolescents and adults. Meningitec should not be injected in the gluteal area.
Avoid injection into or near nerves and blood vessels.
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 - Text added:
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.
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Updated on 16/10/2008 and displayed until 15/12/2008
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 18-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Shelf life has been changed from 18 months to 2 years.
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Updated on 23/07/2008 and displayed until 16/10/2008
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 02-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| ATC Code changed
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Updated on 10/06/2008 and displayed until 23/07/2008
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 24-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In Section 4.4 (Special warnings and precautions for use) we have added the following text:
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born £ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
In Section 4.8 (Undesirable effects) we have added the following text:
Apnoea in very premature infants (£ 28 weeks of gestation) (see section 4.4).
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Updated on 10/04/2008 and displayed until 10/06/2008
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Reasons for adding or updating:
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