Infanrix Hexa, Powder and suspension for suspension for injection

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/07/17

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Summary of Product Characteristics last updated on medicines.ie: 15/2/2019

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 135 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 15 February 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Change to section 4.1 – Therapeutic indications
Added the statement 'The use of Infanrix hexa should be in accordance with official recommendations.'

Change to section 5.1 – Pharmacodynamic properties
Added information on persistence of immunity against hepatitis B up to 14-15 years of age.

 

Updated on 1 June 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 8 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 February 2018 SmPC

Reasons for updating

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

Main change:
Change to section 5.1 – Pharmacodynamic properties
Updated the details regarding persistence of antibodies generated against the hepatitis B antigen in the adolescent population (12-13 years of age)

Editorial/minor changes:
Change to section 4.4 – Special warnings and precautions for use
Included the clarification 'of vaccination' in the statement 'Temperature of greater-than/equal-to 40.0°C within 48 hours of vaccination, not due to another identifiable cause'

Change to section 5.1 – Pharmacodynamic properties
Included the acronym 'DTPa' for the vaccine 'Infanrix'.

Updated on 20 July 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

SPC: Change to section 4.1 – Therapeutic indications
Clarified age range to include the term 'toddler' in addition to the existing term 'infant'.

SPC: Change to section 4.3 – Contraindications
Clarified age range to include the term 'toddler' in addition to the existing term 'infant'.

SPC: Change to section 4.4 – Special warnings and precautions for use
Added statement regarding the prophylactic use of Antipyretic medicine before or immediately after vaccine administration, in order to reduce the incidence and intensity of post-vaccination febrile reactions.

Updated on 18 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 July 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 9 February 2017 SmPC

Reasons for updating

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

SPC: Change to section 6.4 – Special precautions for storage
Updated to include instructions for the use of pre-filled syringes supplied with a PRTC luer lock adaptor, including diagrams.

Updated on 8 February 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Improved presentation of PIL

Updated on 27 September 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • 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 4.8: Changed the table heading ‘Adverse events’ to Adverse reactions’, and for the ‘apnoea’ adverse reaction listed, changed the wording from ‘premature babies’ to ‘preterm babies’.
Section 6.6: Removed the description ‘reconstituted’ from ‘reconstituted mixture’.

SPC has been updated to combine all registered presentations, i.e. prefilled syringe/vial and vial/vial presentations are now combined, resulting in the following changes to the SPC:
Section 1: Removed ‘prefilled syringe’ from the product name.
Section 3: Removed ‘prefilled syringe’ from the description of pharmaceutical form.
Section 6.5: Added subheadings for both prefilled syringe/vial and vial/vial presentations, and added description of the vial/vial presentation.
Section 6.6: Added subheadings for both prefilled syringe/vial and vial/vial presentations, and added instructions for storage, use and handling and disposal for the vial/vial presentation.
Section 8: Added the MA numbers of the vial/vial presentations.

Updated on 27 September 2016 PIL

Reasons for updating

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

Updated on 16 November 2015 SmPC

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

Section 4.2: Addition of posology instructions for use in pre-term infants.

Section 4.4: Revision of warnings for use in pre-term infants, and subsequent re-organisation of text.

Section 4.8: Added statement regarding side effect data in preterm infants.

Section 5.1: Added sub-section and data ‘Immunogenicity in preterm infants

Updated on 28 October 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

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

Free text change information supplied by the pharmaceutical company



EMEA/H/C/0296/II/177
SPC sections 4.4, 4.5 and 4.8 updated safety information of Infanrix hexa on the co-administration with several other paediatric vaccines (pneumococcal conjugate vaccine (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), oral rotavirus vaccine and measles-mumps-rubella-varicella (MMRV) vaccine).

 

EMEA/H/C/0296/II/179 

SPC section 5.1 updated to add data generated in study DTPa-HBV-IPV/Hib-MenC-TT-003 for the new 2+1 schedule (2, 4 and 12 months of age).

SPC section 2: Added abbreviations for the vaccine components, e.g. added (PT) to Pertussis toxoid.

 

EMEA/H/C/0296/II/180
SPC section 5.1 to describe the results of the Hepatitis B immunity persistence data gathered

Updated on 27 October 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 1 October 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 1 October 2015 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 9 September 2015 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 8 September 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

SPC Section 4.8:

·         Added undesirable effects ‘upper respiratory tract infection and bronchitis.

·         Re-categorised thrombocytopenia from being an undesirable effect reported specifically for hepatitis B vaccine to the more general ‘adverse reactions from spontaneous reporting’

·         Under ‘Experience with hepatitis B vaccine’ added allergic reactions mimicking serum sickness, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis and muscular weakness

Updated on 7 September 2015 PIL

Reasons for updating

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

Updated on 24 November 2014 PIL

Reasons for updating

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

Updated on 4 November 2014 SmPC

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
  • 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

Added the following warning: ‘Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Infanrix hexa and Prevenar 13 (see section 4.8).’

 

Section 4.8

Added the following statement under the revised sub-heading ‘Experience in co-administration

Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions (with or without fever) and HHE when comparing groups which reported use of Infanrix hexa with Prevenar 13 to those which reported use of Infanrix hexa alone.

 

SPC editorial updates

Sections 4.4 and 4.8

Changed the term ‘hyporesponsiveness’ to ‘hyporesponsive’ in the description ‘hypotonic hyporesponsive episode

 

Section 4.5

Added reference to section 4.4 for guidance on Prevenar and Prevenar 13.

 

Updated on 28 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • 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

2.         Qualitative And Quantitative Composition

·         Added statement that vaccine may contain traces of formaldehyde, neomycin and polymyxin.

·         Administrative changes.

 

4.2        Posology and method of administration

·         Added: The immunisation schedules for Infanrix hexa should be based on official recommendations.

·         Administrative changes.

 

4.3        Contraindications

·         Added hypersensitivity to formaldehyde.

 

4.8        Undesirable effects

·         Administrative changes.
 

5.1        Pharmacodynamic properties

·         Added data on the effectiveness of Infanrix Hexa in controlling Hib disease, when the vaccine is administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 11 months

·         Reformatted the presentation of data regarding Efficacy in protecting against pertussis into results of clinical studies and reports from post marketing surveillance. No change to the actual data.

·         Administrative changes.

 

6.4        Special precautions for storage

·         Administrative changes.

 

6.5        Nature and contents of container

·         Added new multipack presentation; this presentation is not planned to be launched in IE or UK.

 

6.6        Special precautions for disposal and other handling

·         Administrative changes.

 

8.         MARKETING AUTHORISATION NUMBER(S)

·         Added ‘EU/1/00/152/021’ for the new multipack presentation.

 

9.         Date of First Authorisation/Renewal of the Authorisation

·         Changed the ‘date of last renewal’ to 31/08/2010

Updated on 25 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 25 July 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Improved electronic presentation
  • Change of contraindications

Updated on 28 May 2014 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • 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 6.4 - Special precautions for storage - Update stability data supporting temperature excursion to 25°C for 72 hours.

Section 6.6 - Special precautions for disposal and other handling - Update the handling and preparation instructions.

Section 10 - Update date of revision of text.

Updated on 27 May 2014 PIL

Reasons for updating

  • Change to date of revision

Updated on 10 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 September 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Editorial changes to SPC sections 1, 2, 4.2, 4.8 and 6.6 further to the adoption of the QRD Human Product Information Template for Centralised Procedures (Version 7.3.1, 03/2010)

 

5.1     Pharmacodynamic properties

The statement regarding the effectiveness of the Hib component was updated to reflect the outcome of an extensive post marketing surveillance study conducted over a 7-year follow-up period showed the effectiveness of the Hib components of two hexavalent vaccines, of which one was Infanrix Hexa, was 89.6% for a full primary series (previously 90.4% at 5 year time-point of the study). The effectiveness remained 100% for a full primary plus booster dose, irrespective of the Hib vaccine used for the priming.

Updated on 22 February 2011 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 21 October 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

2.       Qualitative And Quantitative Composition

Minor update to use the correct formula for the Aluminium cation, adding ‘3+’ to read:

Al3+

 

4.4     Special warnings and precautions for use

Minor change to intrduce bullet formatting to the following list:

§   Temperature of ³ 40.0°C within 48 hours, not due to another identifiable cause;

§   Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination;

§   Persistent, inconsolable crying lasting ³ 3 hours, occurring within 48 hours of vaccination;

§   Convulsions with or without fever, occurring within 3 days of vaccination.

 

4.8     Undesirable effects

Under the heading ‘Clinical trials’, sub-heading ‘General disorders and administration site conditions’, removed the side effect ‘injection site reaction

 

Updated on 7 July 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

1.         Name of the Medicinal Product

Added the detail ‘in a pre-filled syringe’ to the pharmaceutical form, to read:

Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe

 

3.         Pharmaceutical Form

Added the detail ‘in a pre-filled syringe’ to the pharmaceutical form, to read:

Powder and suspension for suspension for injection in a pre-filled syringe

 

4.1       Therapeutic indications

Deleted the following statement regarding use in children over 36 months (corresponding statement added to section 4.2):

Infanrix hexa is not intended for use in children over 36 months of age

 

4.2       Posology and method of administration

Added the following statement regarding use in children over 36 months (corresponding statement deleted from section 4.1):

Paediatric population

There is no relevant use of Infanrix hexa in children over 36 months

 

4.6       Fertility, pregnancy and lactation

Added ‘Fertility’ to the heading

 

6.4       Special precautions for storage

Added the following reference to section 6.3:

For storage conditions of the reconstituted medicinal product, see section 6.3.

 

6.6       Special precautions for disposal and other handling

Clarified the statement regarding the observation of the clear supernatant liquid in the syringe, to read:

Upon storage, a white deposit and clear supernatant may be observed in the syringe containing the DTPa-HBV-IPV suspension. This does not constitute a sign of deterioration.

 

10.       Date of Revision of the Text

Updated to 10/05/2010

Updated on 31 March 2009 PIL

Reasons for updating

  • Change to how the medicine works
  • Change of active ingredient
  • Change to dosage and administration
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to side-effects
  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 8 January 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

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

Free text change information supplied by the pharmaceutical company

SPC updates; sections 2, 4.2, 4.4, 4.5, 4.8 and 5.1.

Updated on 28 October 2008 SmPC

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

Section 5.1 Added statements regarding the results of long-term surveillance studies regarding the efficacy of acellular pertussis and Hib components.

Updated on 26 August 2008 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 26 August 2008 PIL

Reasons for updating

  • New PIL for new product