Hiberix

  • Name:

    Hiberix

  • Company:
    info
  • Active Ingredients:

    Haemophilus Influenzae Vaccine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/03/18

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Summary of Product Characteristics last updated on medicines.ie: 30/4/2018
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Amoxil Paediatric Suspension Active Ingredients Amoxicillin trihydrate
Medicine Name Amoxil Vial for Injection 500mg Active Ingredients Amoxicillin sodium
Medicine Name ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed Active Ingredients Umeclidinium bromide, Vilanterol trifenatate
Medicine Name Augmentin 250 mg/125 mg film-coated tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 500mg/125mg Film-coated Tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 875/125mg Film Coated tablets Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin DUO Suspension 400/57mg Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin Intravenous 1.2g Active Ingredients Amoxicillin sodium, Potassium clavulanate
Medicine Name Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name AVAMYS 27.5 micrograms/spray nasal spray suspension Active Ingredients Fluticasone furoate
Medicine Name Avodart Soft Capsules 0.5mg Active Ingredients Dutasteride
Medicine Name Babyhaler Active Ingredients No Active Ingredients
Medicine Name Bactroban Nasal Ointment Active Ingredients Mupirocin calcium
Medicine Name Bactroban Ointment Active Ingredients Mupirocin
Medicine Name Becotide Evohaler 100 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 250 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 50 Active Ingredients Beclometasone Dipropionate
Medicine Name Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion Active Ingredients Belimumab
Medicine Name Betnovate C 0.1% / 3% w/w Cream Active Ingredients Betamethasone Valerate, Clioquinol
Medicine Name Betnovate Cream 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Ointment 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution Active Ingredients Betamethasone Valerate
1 - 0 of 136 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 30 April 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 April 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 April 2018 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

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.

Updated on 29 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 March 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 April 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 25 April 2016 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • 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

#4.6: 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.

Updated on 22 April 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Improved electronic presentation

Updated on 27 October 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 27 October 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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 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

·         #6.6 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).

 

Updated on 17 July 2015 SmPC

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)

Free text change information supplied by the pharmaceutical company

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.

 

Updated on 16 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 28 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 28 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 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

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

Updated on 28 June 2013 SmPC

Reasons for updating

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

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 4.4 - Special warnings and precautions for use

 

Updated on 27 June 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 August 2012 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
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

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’.

Updated on 30 August 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 23 June 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change due to harmonisation of patient information leaflet

Updated on 14 May 2010 SmPC

Reasons for updating

  • 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

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

Updated on 1 April 2010 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions

Updated on 8 December 2009 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.2 - Incompatibilities

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

Free text change information supplied by the pharmaceutical company

'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 9th November 2004 to read:

October 2009

Updated on 9 February 2006 SmPC

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 23 November 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 4 August 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 July 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

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

Updated on 6 August 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form

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

Updated on 9 February 2004 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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