Engerix B 10mcg Prefilled Syringe

  • Name:

    Engerix B 10mcg Prefilled Syringe

  • Company:
    info
  • Active Ingredients:

    Hepatitis B 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: 04/11/15

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Summary of Product Characteristics last updated on medicines.ie: 5/11/2015
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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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 5 November 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 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: update in line with QRD format

Section 4.2 -  update in line with QRD format

Section 4.4 -  Special warnings- replaced intravenously with intravascularly

Section 4.6 – minor format update

Section 4.7 Deletion of text

Section 4.8 Update to summary of safety profile

Section 5.1 Update to Pharmacodynamic effects

Section 6.4 Deletion of text

Section 6.5 - Deletion of pack sizes

Updated on 4 November 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 November 2015 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

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 marketing authorisation holder

Updated on 5 December 2014 SmPC

Reasons for updating

  • 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

Section 5.1 – addition of seroprotection rates from neonatal clinical data – (addition of data from Persistence studies)

Section 6.6 – precautions for handling vaccine

Updated on 22 November 2012 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 4.4 - 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 6.5 - 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)

Free text change information supplied by the pharmaceutical company

SPC changes

 

Minor editorial changes to sections 3, 4.1, 4.2, 4.4, 4.8, 6.5 and 6.6

 

4.3       Contraindications

Reworded the hypersensitivity warning from:

ENGERIX B should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous ENGERIX B administration.

to

ENGERIX B should not be administered to subjects with known hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to subjects having shown signs of hypersensitivity after previous ENGERIX B administration.

 

4.5       Interaction with other medicinal products and other forms of interaction

Added the following statement regarding coadministration with Cervarix:

ENGERIX B can be given concomitantly with Human Papillomavirus (HPV) vaccine.

Administration of ENGERIX B at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV antigens. Anti-HBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 97.9% for concomitant vaccination and 100% for ENGERIX B alone.

 

4.6       Fertility, pregnancy and lactation

Changed the subheading ‘Lactation’ to ‘Breastfeeding

 

Added the subheading ‘Fertility’ with the following statement

Fertility

ENGERIX B has not been evaluated in fertility studies.

 

5.1       Pharmacodynamic properties

Tabulated the results of seroprotection rates in healthy subjects up to and including 15 years of age and included the explanation that these results were generated with thiomersal containing vaccines. and that two additional clinical studies conducted with the current formulation of ENGERIX B, which does not contain thiomersal, among healthy infants and adults, elicit similar seroprotection rates as compared to former thiomersal containing formulations of ENGERIX B.

 

Updated the results of seroprotection rates in healthy subjects from 11 years up to and including 15 years of age to include data for up to 66 months after the first dose, obtained in a comparative study with the two different dosages (Junior 10µg/0.5ml and Adult 20µg/1ml) and schedules licensed in subjects from 11 years up to and including 15 years of age, and added the following statement:

All subjects in both vaccine groups (N=74) received a challenge dose 72 to 78 months after primary vaccination. One month later, all subjects mounted an anamnestic response with a GMC increase of 108 and 95 fold from the pre-to the post challenge time points in the 2-dose and 3-dose priming schedule respectively and were shown to be seroprotected. These data suggest that immune memory was induced in all subjects who responded to primary vaccination, even among those who had lost seroprotection at Month 66.

 

6.2       Incompatibilities

Updated to read:

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

 

 

 

CARTON

Updated the storage instruction/warning to read:

Keep out of the sight and reach of children.

 

Updated on 9 November 2012 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to information about pregnancy or lactation
  • Change of special precautions for disposal

Updated on 15 March 2012 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 14 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 13 September 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change due to harmonisation of PIL
  • Change due to user-testing of patient information

Updated on 28 June 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 6.6 - Special precautions for disposal and other handling

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

Updated the active substance name to read:

Hepatitis B (rDNA) vaccine (adsorbed) (HBV)

 

3.          Pharmaceutical Form

Added the description:

Turbid white suspension.

 

4.4        Special warnings and special precautions for use

Added the following warning regarding the potential risk of apnoea following administration the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity:

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

 

4.6        Fertility, pregnancy and lactation

Updated heading to include ‘fertility’.

 

4.8        Undesirable effects

Reorganised under the subheadings ‘Clinical trials’ and ‘Post-marketing surveillance’ with revision of side effects to reflect data from Clinical trials and Post-marketing surveillance (PMS):

Frequency categories were changed for the following

·                 Rare to very common: Headache, fatigue

·                 Common to very common: Pain and redness at injection site

·                 Rare to common: Nausea, vomiting, diarrhoea, abdominal pain, fever, malaise

·                 Rare to uncommon: Dizziness, myalgia, influenza-like symptoms

·                 Very rare to rare: Lymphadenopathy

·                 Very rare to frequency unknown, observed in PMS: Thrombocytopenia, encephalitis, encephalopathy, convulsions, paralysis, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), neuropathy, vasculitis, hypotension, erythema multiforme, anaphylaxis, angioneurotic oedema, arthritis, meningitis

·                 New, very common: Irritability

·                 New, common: Drowsiness, appetite lost

·                 New, frequency unknown, observed in PMS: Apnoea in very premature infants (≤ 28 weeks of gestation), hypoaesthesia, muscular weakness, allergic reactions including anaphylactoid reactions and mimicking serum sickness, lichen planus

·                 Deleted: Syncope, bronchospasm, hepatic function abnormal, serum sickness

 

Please note that there was no change to the following:

·          Rare: Paraesthesia, arthralgia, urticaria, pruritus, rash

·          Common: Injection site induration

 

4.9        Overdose

Updated wording (previously ‘not applicable’) to read:

Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.

 

5.1        Pharmacodynamic properties

Deleted references to the composition and production of the vaccine.

 

Added a statement that the pharmacodynamic data generated for the vaccine were generated with thiomersal containing vaccines, and that two additional clinical studies conducted with the current formulation of Engerix B, which contains no thiomersal, among healthy infants and adults, elicit similar seroprotection rates as compared to former thiomersal containing formulations of Engerix B.

 

6.6        Special precautions for disposal and other handling

Updated heading to ‘Special precautions for disposal and other handling’

 

Added the statement regarding disposal:

Any unused product or waste material should be disposed of in accordance with local requirements.

Updated on 22 November 2010 SmPC

Reasons for updating

  • 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



Section 4.4:

Delete the sentence:

Thiomersal (an organomercuric compound) has been used in the manufacturing process of this medicinal product and residues of it are present in the final product. Therefore, sensitisation reactions may occur.

 

Section 10

Update to read:

April 2007

Updated on 17 June 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 27 August 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 29 August 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 31 January 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 July 2005 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 11 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 July 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 7 - Marketing authorisation holder
  • 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)

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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