Engerix B 20mcg Prefilled Syringe

*
Pharmacy Only: Prescription
  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Legal 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 13 June 2024

File name

ie-pl-engerixbadultpfs-Medicines IE.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

SmPC Section 5 - addition of 'in order to protect from light' 

SmPC Section 6 - removal of pack size 25 from pre-filled syringes and pack size 3 from vials. Date of revision updated to 2024. 

Updated on 13 June 2024

File name

ie-spc-engerixbadultpfs-issue6draft1-Medicines IE.pdf

Reasons for updating

  • 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

SmPC Section Section 6.4 - relocating the 'Do not freeze' text and including 'Store in the original package in order to protect from light'

SmPC Section 6.5 - removal of pack size 25. 

Updated on 06 December 2023

File name

ie-pl-engerixbadultpfs-issue5draft1-Master.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to date of revision
  • Change to section 7 - Instructions for use

Updated on 31 May 2023

File name

ie-spc-engerixbadultpfs-issue5draft1_working copy-clean (1).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 31 January 2022

File name

ie-spc-engerixbadultpfsqrdissue4draft1-clean.pdf

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)

Updated on 31 January 2022

File name

ie-pl-engerixbadultpfsqrdissue4draft1-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 September 2020

File name

ie-pl-engerixbadultpfsqrdissue3draft1.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

PIL #2: Changed the statement regarding ability to drive from 'may affect' to ‘unlikely to affect'.

PIL #4: Revised the HPRA reporting details to align with the current guideline.

PIL #6: Change date of revision to April 2020

Information directed to Healthcare Professionals: Revised instructions regarding visual inspection of the vaccine prior to use, and in particular replaced the 'Discard...' instruction with the instruction 'Do not administer the vaccine' in the event of foreign particulate matter and/or abnormal physical appearance.

Updated on 29 September 2020

File name

ie-spc-engerixbadultpfsqrdissue3draft1.pdf

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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

SPC # 4.7: Revised statement to 'no or negligible effect'.

SPC #4.8: Revised the HPRA reporting details to align with the current guideline.

SPC #6.4: Removed the instruction to 'discard if frozen', and added statement regarding thermostability intended for healthcare professionals in the event of temperature excursions only.

SPC #6.6: Revised instructions regarding visual inspection of the vaccine prior to use, and in particular replaced the 'Discard...' instruction with the instruction 'Do not administer the vaccine' in the event of foreign particulate matter and/or abnormal physical appearance.

SPC #10: Change the date of revision to 23/09/2020

Updated on 07 October 2015

File name

PIL_15138_326.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 October 2015

Reasons for updating

  • Change to improve clarity and readability
  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 06 October 2015

Reasons for updating

  • New SPC for new product

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

Updated on 06 October 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Section 4.1 Update to Therapeutic indications

Section 4.2 -  minor format update

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 Update to pack sizes

Section 7 MAH address update

Updated on 06 October 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 17 July 2015

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.

 

Updated on 16 July 2015

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 22 November 2012

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 09 November 2012

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

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

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 13 September 2011

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

Updated on 28 June 2011

Reasons for updating

  • 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
  • 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

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

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 09 February 2006

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 22 July 2005

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 22 July 2004

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 6.3 - 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 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 19 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 25 June 2003

Reasons for updating

  • New SPC for medicines.ie

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