Infanrix Hexa, Powder and suspension for suspension for injection
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 October 2024
File name
Direct Healthcare Professional Communication.pdf
Reasons for updating
- New ADCOM File
Updated on 14 August 2024
File name
ie-spc-combined-infanrixhexa-issue19draft1-clean - no headers.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- 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)
Updated on 14 August 2024
File name
ie-pl-combined-infanrixhexa-issue14draft1-clean - no headers.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 4 - how to report a side effect
Updated on 17 May 2023
File name
ieukni-spc-combined-infanrixhexa-issue17draft1-Master.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 May 2023
File name
ieukni-spc-combined-infanrixhexa-issue16draft1-Master (2).pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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)
Updated on 10 May 2023
File name
ieukni-pl-combined-infanrixhexa-issue12draft1-Master.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to information for healthcare professionals
Updated on 06 April 2022
File name
ieukni-spc-combined-infanrixhexa-issue15draft1-clean.pdf
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 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2022
File name
ieukni-pl-combined-infanrixhexa-issue11draft1-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to further information section
Updated on 26 September 2020
File name
ie-pl-infanrixhexaissue10draft2.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Changed date of revision from '08/2020' to '09/2020'
Updated on 07 September 2020
File name
ie-pl-infanrixhexaissue10draft2.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
3 How Infanrix hexa is given
- Added clarification regarding the interval between dosing, i.e. 2 months between doses in a 2-dose schedule, and 1 month between doses in a 3 dose schedule
4 Possible side effects
- Clarified the instruction regarding consulting ones doctor if the child experiences fits ‘with or without fever’, replacing the statement that such fits may be when they have a fever.
- Changed the frequency of the side effect ‘sleepiness’ from uncommon to very common, and the frequency of ‘feeling tired’ from very common to uncommon and renamed it as ‘tiredness’.
- Revised the HPRA contact details for reporting adverse reactions
6 Contents of the pack and other information
- Editorial changes to the contact details of the MA holder representatives in the following countries: Belgium, Greece, Spain, Netherlands, Norway and Finland .
Healthcare professional section of Package Leaflet
- Replaced the instruction ‘discard the vaccine’ to ‘do not administer the vaccine’ if any foreign particulate matter and/or abnormal physical appearance when the vaccine is visually inspected before and after reconstitution
Updated on 07 September 2020
File name
ie-spc-infanrixhexaissue14draft2.pdf
Reasons for 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
- 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
4.4 Special warnings and precautions for use
- Added the subheading ‘Traceability’ and advisory text regarding the clear recording of the name and batch number of the administered product.
4.8 Undesirable effects
- Added the subheading ‘Safety in infants and toddlers born to mothers vaccinated with dTpa during pregnancy’ with statements regarding the administration of Infanrix to subjects born to mothers that had been vaccinated with dTpa during the third trimester of pregnancy, and the safety profile of Infanrix hexa being similar regardless of the exposure/non-exposure to dTpa during pregnancy.
- Changed the frequencies of the following adverse reactions:
- Somnolence, from uncommon to very common
- Fatigue, from very common to uncommon
- Revised the HPRA contact details for reporting adverse reactions.
5.1 Pharmacodynamic properties
- Added the subheading ‘Immunogenicity in infants and toddlers born to mothers vaccinated with dTpa during pregnancy’, with corresponding data and statements.
6.6 Special precautions for disposal and other handling
Replaced the instruction ‘discard the vaccine’ to ‘do not administer the vaccine’ if any foreign particulate matter and/or abnormal physical appearance when the vaccine is visually inspected before and after reconstitution.
10 Date of Revision of text
- Changed date from 01/08/2019 to 03/09/2020
Updated on 12 December 2019
File name
ie-pl-infanrixhexaissue9draft1.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 6:
Deleted reference to the 20 and 50 single dose packs.
Changed the date of evision from 07/2017 to 08/2019
Updated on 12 December 2019
File name
ie-spc-infanrixhexaissue13draft1.pdf
Reasons for updating
- 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 - Marketing authorisation number(s)
- 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
6.5 Nature and contents of container
Deleted all reference to the vial presentation and deleted reference to the 20 and 50 single dose packs.
6.6 Special precautions for disposal and other handling
Deleted all reference to the vial presentation.
8. MARKETING AUTHORISATION NUMBER(S)
Deleted the MA numbers of the presentations that have been discontinued, i.e. EU/1/00/152/003, 004, 007, 008, 019 and 020.
10. Date of Revision of the Text
Changed the date of revision from 07/02/2019 to 01/08/2019
Updated on 15 February 2019
File name
ie-spc-infanrixhexaissue12draft1 for medicines.ie.pdf
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 01 June 2018
File name
ie-spc-infanrixhexa.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
File name
ie-spc-infanrixhexaissue11draft1.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
File name
ie-spc-infanrixhexaissue11draft1.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
File name
ie-spc-infanrixhexaissue11draft1.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
File name
ie-spc-infanrixhexaissue11draft1.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
File name
ie-spc-infanrixhexaissue11draft1.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 May 2018
File name
ie-spc-infanrixhexaissue11draft1.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 May 2018
File name
ie-spc-infanrixhexaissue11draft1.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2018
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
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
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
File name
PIL_13594_309.pdf
Reasons for updating
- New PIL for new product
Updated on 18 July 2017
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 09 February 2017
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
Updated to include instructions for the use of pre-filled syringes supplied with a PRTC luer lock adaptor, including diagrams.
Updated on 08 February 2017
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
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
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 16 November 2015
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
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
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 01 October 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
Updated on 01 October 2015
Reasons for updating
- Previous version of PIL reinstated
Updated on 09 September 2015
Reasons for updating
- Change to improve clarity and readability
Updated on 08 September 2015
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 07 September 2015
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
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 04 November 2014
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
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
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
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
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
Reasons for updating
- Change to date of revision
Updated on 10 November 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 13 September 2011
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
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 21 October 2010
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 07 July 2010
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):
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
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 08 January 2009
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
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
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
Reasons for updating
- New PIL for new product