Fendrix suspension for injection

  • Name:

    Fendrix suspension for injection

  • Company:
    info
  • Active Ingredients:

    Hepatitis B vaccine (rDNA)

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/12/18

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Summary of Product Characteristics last updated on medicines.ie: 24/11/2014
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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
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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 5 December 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 23 November 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 November 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 24 November 2014 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 November 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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  - Posology and method of administration

-       Clarity on primary immunisation schedule

 

Section 4.3 – Contraindications

-       Administration of Fendrix should be postponed in subjects suffering from Action Severe febrile illness

 

Section 4.5 – Interactions

-       Interactions with immunosuppressive treatment

 

Section 4.6 – Pregnancy

-       Clarity on ‘no data’ available in pregnancy

 

Section 4.8 – addition of reporting adverse events info

 

Section 4.9 – overdose

-       Amendment to text that limited data is available on overdose

 

 

 

 

 

 

 

Section 10 - change to date of revision of text

Updated on 24 November 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 11 July 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 - update to AE reporting

Updated on 8 July 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

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 2 December 2010 PIL

Reasons for updating

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

Updated on 21 October 2010 SmPC

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • 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

4.1       Therapeutic indications

Minor change to bring ‘in adolescents and adults from the age of 15 years onwards’ from then end of the paragraph to the beginning, to read:

Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).

 

4.2       Posology and method of administration

Minor changes to formatting of headings (i.e. use of underlining and italics)

 

Added subheading and statement regarding the use of Fendrix in the ‘Paediatric population’, i.e.:

Paediatric population

 

The safety and efficacy of Fendrix in children aged less than 15 years have not been established.

 

4.6       Fertility, pregnancy and lactation

Added ‘Fertility’ to the heading and added the subheading ‘Fertility’ with the statement that:

No fertility data are available

 

4.7       Effects on the ability to drive and use machines

Revised statement regarding ability to drive by removing reference to ‘minor’ influence, to read:

Fendrix has moderate influence on the ability to drive and use machine.

 

4.8       Undesirable effects

Added the bullet point subheading ‘Clinical trials’

 

Deleted the following:

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

 

Moved the statement regarding allergic reactions from the listing of side effects due to Fendrix and placed it under the subheading ‘Experience with hepatitis B vaccine’, to read:

Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness  have also been reported very rarely with hepatitis B vaccines.

 

6.3       Shelf life

Removed hyphenation from the heading to read ‘Shelf life

 

6.6       Special precautions for disposal and other handling

Changed the description from ‘vaccine’ to ‘product’ in the statement regarding disposal

Updated on 18 March 2010 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company



SPC UPDATES

 

Minor editorial changes are not described

 

Section 4.2 Posology and method of administration

Replaced word ‘dosage’ with ‘posology’

 

Section 4.4 Special warnings and precautions for use

The following paragraph has been moved from the end to the beginning of the section:

Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

 

Section 4.8 Undesirable effects

Deleted the statement ‘Fendrix was generally well tolerated’ and updated the terms ‘adverse events’ and ‘undesirable events’ to ‘adverse reactions’.

 

Updated on 27 April 2009 PIL

Reasons for updating

  • Change to side-effects
  • Change to warnings or special precautions for use

Updated on 25 March 2009 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: Removed warning regarding the risk of sensitisation due to residual thiomersal preservative as approval was granted to no longer use thiomersal in the manufacturing process.

Section 4.8: Rearrangement of side effects in line with approved QRD version 7.2: No additional side effects or changes to frequency of side effects.

Updated on 24 June 2008 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 24 June 2008 PIL

Reasons for updating

  • New PIL for new product