Prevenar 13 suspension for injection *
Pharmacy Only: Prescription

Updated on 08 November 2021

File name

Adv PIL PN 23_0 IE NI clean_1636389384.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Individual PILs superseded by joint PIL

Updated on 01 December 2020

File name

DEC202079950_Adv SPC PN 25_0 IE clean_1606806316.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Updated inline with QRD template and/or excipient guideline

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 of section 4.8 to add the adverse reaction anaphylaxis with a frequency not known to the group of children above 5 years of age and adults. The MAH has taken the opportunity to move all events reported in the post marketing setting (not only anaphylaxis) from an age specific subsection (6 weeks to 5 years) into a subsection addressing all age ranges. Minor updates in line with QRD 10.1 template.

Updated on 01 December 2020

File name

DEC202079950_Adv PIL PN 22_0 IE clean_1606806209.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 31 January 2020

File name

DEC202004396_Adv PIL PN 20_0 UK+IE clean_1580472820.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 December 2019

File name

DEC201969853_Adv SPC PN 24_0 IE_clean_1576480319.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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 of section 5.1 with data on effectiveness in adults 65 years and older following the CAPiTA Public Health analysis.

Updated on 25 July 2019

File name

Adv PiL PN 19_1 UK+IE clean_1564037586.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 July 2019

File name

Adv SPC PN 23_1 IE clean_1564037617.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Please be advised that above country regulatory have agreed a new revision date for the Prevenar SPC and  leaflet associated with this pack size variation change with EMA due to it being resubmitted for other presentations. The approval of the Type IA in variation is now the revision date for both the section 10 of the EU SmPC and corresponding section of the leaflet.

 

Updated on 30 April 2019

File name

DEC201922171_Adv PiL PN 19_0 UK+IE_clean_1556620644.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 30 April 2019

File name

DEC201922171_Adv SPC PN 23_0 IE_clean_1556620713.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 02 October 2018

File name

Adv PiL PN 17_0 UK+IE clean_1538491911.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 02 October 2018

File name

Adv SPC PN 22_0 IE clean_1538491999.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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The SPC has been updated as follows|;
SECTION 7 – Change to MAH

SECTION 10 – Date of revision of text

Updated on 23 April 2018

File name

Adv_PiL_PN_17_0_UK+IE_date_correction_CLEAN.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 09 March 2018

File name

PIL_14821_196.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 March 2018

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 6 - manufacturer

Updated on 12 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 January 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects

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 11 January 2018

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 27 March 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

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SPC

UK brand marketing

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

Updated on 19 December 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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 December 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

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4.5       Interaction with other medicinal products and other forms of interaction

Updated on 22 November 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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 August 2016

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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The date of revision is changing from June 2016 to July 2016 as agreed by Above country regulatory with the EMA

Updated on 19 August 2016

Reasons for updating

  • Change to date of revision

Updated on 12 July 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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 11 July 2016

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 03 May 2016

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

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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 29 April 2016

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 09 December 2015

Reasons for updating

  • Change to information about driving or using machinery
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 19 November 2015

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties

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 17 November 2015

Reasons for updating

  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 22 October 2015

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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 05 May 2015

Reasons for updating

  • Improved electronic presentation

Updated on 09 March 2015

Reasons for 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

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 05 March 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 29 September 2014

Reasons for 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

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 22 September 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 26 August 2014

Reasons for updating

  • Improved electronic presentation

Updated on 06 July 2014

Reasons for 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

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 02 July 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 01 April 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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 December 2013

Reasons for 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

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 November 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 28 October 2013

Reasons for 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

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 22 October 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 16 July 2013

Reasons for 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

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 12 July 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Addition of marketing authorisation holder

Updated on 17 January 2013

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Product subject to medical prescription which may not be renewed (A)

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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 11 January 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 17 December 2012

Reasons for 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

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 28 November 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Improved electronic presentation

Updated on 18 July 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Product subject to medical prescription which may not be renewed (A)

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Section 7 – Marketing Authorisation Holder and Manufacturer

Updated on 12 July 2012

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 02 April 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

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Section 4.2 – Posology and method of administration

Section 5.1 - Pharmacodynamic properties



Updated on 29 March 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 09 November 2011

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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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 04 November 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Changes to therapeutic indications

Updated on 14 December 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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 October 2010

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 13 October 2010

Reasons for updating

  • New PIL for new product