Hiberix

Information directed to healthcare professionals: Added information on the use and handling of Plastic Rigid Tip Cap (PRTC) syringes containing the solvent used for the reconstitution of the vaccine.

Section 4: Updated the HPRA details for adverse event reporting.

Section 6: Changed the date of revision to October 2019.

Section 6.6: Added information on the use and handling of Plastic Rigid Tip Cap (PRTC) syringes containing the solvent used for the reconstitution of the vaccine.

Section 4.8: Updated the HPRA details for adverse event reporting.

Section 5.1: Removed reference statement from the footer of Table 1.

Section 10: Changed the date of revision to 19 December 2019.

Change to section 4.8 – Undesirable effects
Under 'Post-marketing surveillance' updated the Skin and subcutaneous tissue disorder 'rash' to include the clarification that it included local and generalised rash.

#4.6: Reformatted to introduce two subheadings ‘pregnancy’ and ‘lactation’, with revised wording to specify that no human data is available for use in pregnancy or lactation

# 4.8: Updated side effect profile with safety data from study HIB-097 and study DTPa-HBV-IPV-011.

#4.9: Updated with currently available information reported in the Periodic Safety Update Reports, and aligned with current guidance.

#5.1: Updated with immunogenicity data from study HIB-097 and general revision of the Pharmacodynamics section to provide additional clinical trial data to prescribers, and to align with current guidance.

#6.5: Removed reference to the vial presentation of diluent, which is now discontinued.

·         #6.6 Revised description of appearance of reconstituted vaccine from ‘clear and colourless solution’ to ‘clear to opalescent and colourless solution’

·         #6.6 Added ‘ampoules’ to the instructions for reconstitution

·         #4.8 Updated the AE reporting contact details of the HPRA from the superseded name ‘IMB’

·         # 1, 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 6.1, 6.3, 6.4, 6.5 and 6.6 Updated with formatting changes to align with EU Guidance (QRD template).

 

Section 7 - Change to address of the Irish MA Holder from Stonemasons Way, Rathfarnham, Dublin 16 to 12 Riverwalk, Citywest Business Campus, Dublin 24.

Section 10 - change to date of revision of text.

 

GDS007 updates:

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Updated the quantitative description of the tetanus toxoid from 30 µg to 25 µg

 

5.1.         Pharmacodynamic properties

Added the pharmaco-therapeutic group and ATC code

 

6.6.         Special precautions for disposal

Changed instructions for reconstitution using the PRTC syringe.

 

Administrative updates:

4.3.         Contraindications

4.5.       Interaction with other medicinal products and other forms of interaction

4.7.         Effects on ability to drive and use machines

4.8.         Undesirable effects

6.4.         Special precautions for storage

6.5.         Nature and contents of container

Change to:

 

 

Section 4.4 - Special warnings and precautions for use

 

The changes to the SPC are as follows:

Section 2 Qualitative and Quantitative Composition

Added statement regarding the quantity of sodium per dose.

 

Section 4.4 Special warnings and precautions for use

Added statement regarding the quantity of sodium per dose, explaining that it is essentially ‘sodium free’

 

Section 4.8 Undesirable effects

Corrected to add ‘Very rarely allergic reactions, including anaphylactoid reactions, have been reported’. Please note that this undesirable effect was already included under the system organ class ‘Immune system disorders

 

Section 6.4 Special precautions for storage.

Added ‘Do not freeze’.

 

Section 6.5 Nature and contents of container

Added pack description ‘Pack sizes of 1 with or without needles’.

Section 4.4 Special warnings and precautions for use

Added the following statements regarding the risk of apnoea following vaccination in prematurely born infants:

The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particulary for those with a previous history of respiratory immaturity.

 

As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

 

Section 4.8 Undesirable effects

Split the section under the sub-headings ‘Clinical trials’ and ‘Post marketing surveillance’.

 

Deleted the following statement regarding allergic reactions:

Very rarely allergic reactions, including anaphylactoid reactions have been reported

 

Added the following list of side effects as reported during Post marketing surveillance and including apnoea in very premature infants:

Undesirable effects reported are listed according to the following frequency:

Very rare <1/10000

 

Immune system disorders

Very rare: allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema

 

Nervous system disorders

Very rare: hypotonic-hyporesponsive episode, convulsion (with or without fever), syncope or vasovagal responses to injection, somnolence

 

Respiratory, thoracic and mediastinal disorders

Very rare: Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)

 

Skin and subcutaneous tissue disorders

Very rare: urticaria, rash

 

General disorders and administration site conditions

Very rare: extensive swelling of vaccinated limb, injection site induration

'Hiberix'. Haemophilus Type b (Hib) vaccine

Powder and Solvent for Solution for Injection.

 

Summary of changes to SPC, labelling and package leaflet further to approval of renewal on 23/10/2009

 

SUMMARY OF PRODUCT CHARACTERISTICS

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Added the following reference regarding excipients:

For a full list of excipients see section 6.1.

 

3.         PHARMACEUTICAL FORM

Added the following description of the medicinal product:

Powder: white powder

Solvent: clear colourless aqueous solution

 

4.4.      Special warnings and precautions for use

The title of section 4.2 is included in the reference to that section, i.e.:

see Section 4.2, Posology and method of administration.

 

4.5.      Interactions with other medicaments and other forms of interaction

The instruction to use different injection sites has been reformatted as bold text:

Different injectable vaccines should be administered at different injection sites.

 

6.2.      Incompatibilities

The statement has been updated from:

'Hiberix' should not be mixed with other vaccines in the same syringe, unless specified by the manufacturer

 

to

In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.

 

6.3.      Shelf-life

The description of storage has been updated from:

The shelf-life of the 'Hiberix' vaccine is three years when stored unopened and unmixed at 2C to 8C.

 

to:

The shelf-life of the 'Hiberix' vaccine is three years when stored as packaged for sale at 2C to 8C.

 

6.5.      Nature and contents of container

Added description of glass vial:

a type I glass vial.

 

Deleted description of syringe as ‘prefilled’

 

6.6.      Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Updated heading from Instructions for use/handling

 

7.         MARKETING AUTHORISATION HOLDER

Included Ireland in the address.

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

Updated from ‘24 August 2004’ to read

Date of first authorisation: 11 June 1999

Date of last renewal: 11 June 2009

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

Updated from 9^th November 2004 to read:

October 2009