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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
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 12/01/2018
SPC Prevenar 13 suspension for injection

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 12/01/2018 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jan-2018
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Update to section 2 to reflect the quantity of protein CRM197 and clarify that the active substance is the conjugated polysaccharides to avoid misinterpretation. Update to section 4.8 to update MHRA AE reporting details to include the Google Play / Apple App.
Updated on 27/03/2017 and displayed until 12/01/2018
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Feb-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



SPC

UK brand marketing

Please implement in line with REG08-WI-GBR04 SPC release and withdrawal

Updated on 19/12/2016 and displayed until 27/03/2017
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Nov-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows:

Addition of text in section 4.5 of the SPC ‘Interaction with other medicinal products and other forms of interaction’

4.5       Interaction with other medicinal products and other forms of interaction

 

Updated on 14/12/2016 and displayed until 19/12/2016
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Nov-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



4.5       Interaction with other medicinal products and other forms of interaction

Updated on 22/11/2016 and displayed until 14/12/2016
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Nov-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows:

Addition of text in section 4.5 of the SPC ‘Interaction with other medicinal products and other forms of interaction’

4.5       Interaction with other medicinal products and other forms of interaction

 

Infants and children aged 6 weeks to 5 years

 

Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see section 4.4 for guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine.

 

Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations).

Updated on 22/08/2016 and displayed until 22/11/2016
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The date of revision is changing from June 2016 to July 2016 as agreed by Above country regulatory with the EMA
Updated on 12/07/2016 and displayed until 22/08/2016
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Jun-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows:

Addition of text in section 4.5 of the SPC ‘Interaction with other medicinal products and other forms of interaction’

Adults aged 50 years and older

 

(…)

In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV). The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone.

 

The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with QIV compared to when Prevenar 13 was given alone. As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly.

Updated on 03/05/2016 and displayed until 12/07/2016
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Apr-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows: Update to section 6.6 of the SPC, addition of text in blue below:

‘During storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of deterioration.’
Updated on 19/11/2015 and displayed until 03/05/2016
Reasons for adding or updating:
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Oct-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows:

Section 4.7 – Addition of text relating to ‘Driving and using machinery’

Section 5.1 – Addition of effectiveness data
Updated on 22/10/2015 and displayed until 19/11/2015
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Sep-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Update of section 4.5 of SmPC: Duration of immunity after concomitance with TIV
Updated on 09/03/2015 and displayed until 22/10/2015
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Feb-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows

Section 4.1 – Therapeutic Indications - To extend the indication to include pneumonia for adults aged 18 years and over

Section 4.8 -  Sub heading-  Adults ≥18 years and the elderly – Update to data on clinical studies

 

Section 5.1 - Sub heading-  Adults ≥18 years and the elderly – Update to data on CAP and IPD

 

Section 5.1removal of the following statement from the EU SmPC

“The European Medicines Agency has deferred the obligation to submit the results of studies with Prevenar 13 in one or more subsets of the paediatric population in pneumococcal disease (See section 4.2 for information on paediatric use)”

-          This statement is an obligatory statement in the SmPC for all products with a PIP which has deferred studies.  This was the first opportunity to remove the statement following completion of our PIP in 2014.

 

Section 5.1 – Addition of sub-heading – “Efficacy study in adults 65 years and older”- information added to the SPC relating to the CAPiTA study.

 

Section 9:  Editorial update to text

Section 10:  Date of revision of text update to 02/2015

Updated on 29/09/2014 and displayed until 09/03/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Sep-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.4- Addition of wording on sodium

Section 4.8 – Update to reporting of side effects details from IMB to HPRA

Minor updates to section 5.2 and 5.3

Section 9 – Addition of date of last renewal date

Section 10 – Update to date of revision to 09/2014
Updated on 06/07/2014 and displayed until 29/09/2014
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:   01-Jun-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Updates to Sections: 4.2, 4.4, 4.8, 5.1 & 10

Updated on 01/04/2014 and displayed until 06/07/2014
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   03-Feb-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Wording has been added:

‘Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics
(ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of
paracetamol concomitantly or within the same day of vaccination may reduce the immune response to
Prevenar 13 after the infant series. Responses to the booster dose administered at 12 months were
unaffected. The clinical significance of this observation is unknown.’

Updated on 06/12/2013 and displayed until 01/04/2014
Reasons for adding or updating:
  • 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 - how to report a side effect
Date of revision of text on the SPC:   01-Nov-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.4
Section 4.5
Section 4.8
Updated on 28/10/2013 and displayed until 06/12/2013
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
Date of revision of text on the SPC:   02-Sep-2013
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
Section 4.4
Section 4.8
Section 5.1

Updated on 16/07/2013 and displayed until 28/10/2013
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • 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:   01-Jul-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



To expand the indication to include adults aged 18-49 years.

The following sections of the SPC have been updated:

4.1 Therapeutic indication

4.2 Posology and method of administration

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

4.8 Undesirable effects

5.1 Pharmacodynamic properties

10 – Date of revision of text.

Updated on 17/01/2013 and displayed until 16/07/2013
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   03-Dec-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Update to section 4.1 :
Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 17 years of age.
Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.

Updated on 17/12/2012 and displayed until 17/01/2013
Reasons for adding or updating:
  • 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 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   01-Nov-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.4 and 4.8 – information regarding Prevenar 13v and Infarix neurological events

Section 4.5- addition of Rotavirus vaccine

Section 4.6 – addition of headings and text in line with QRDv8 template

Section 5.1 – addition of information on Nasopharyngeal Carriage

Section 6.4 – addition of temporary temperature excursion text

Addition of headings and minor text updates to bring SPC in line with QRDv8

Updated on 18/07/2012 and displayed until 17/12/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Jul-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 7 – Marketing Authorisation Holder and Manufacturer

Updated on 02/04/2012 and displayed until 18/07/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Mar-2012
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 – Posology and method of administration

Section 5.1 - Pharmacodynamic properties



Updated on 09/11/2011 and displayed until 02/04/2012
Reasons for adding or updating:
  • 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 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.1 – Therapeutic indications

Section 4.2 – Posology and method of administration

Section 4.4 – Special warnings and precautions for use

Section 4.5 - Interaction with other medicinal products and other forms of interaction

Section 4.6 - Fertility, pregnancy and lactation

Section 4.8 - Undesirable effects

Section 5.1 - Pharmacodynamic properties

Section 5.3 - Preclinical safety data

Updated on 14/12/2010 and displayed until 09/11/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
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


Section 5.1 the following paragraph has been added:
Immune responses after subcutaneous administration
Subcutaneous administration of Prevenar 13 was evaluated in a non-comparative study in 185 healthy Japanese infants and children who received 4 doses at 2, 4, 6 and 12-15 months of age. The study demonstrated that safety and immunogenicity were generally comparable with observations made in studies of intramuscular administration.

Section 4.4 the following paragraph has been amended:
This vaccine should not be given as an intramuscular injection to infants or children with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1).
Updated on 13/10/2010 and displayed until 14/12/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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