Twinrix Adult, suspension for injection

  • Name:

    Twinrix Adult, suspension for injection

  • Company:
    info
  • Active Ingredients:

    Hepatitis A Vaccine, Hepatitis B

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/10/18

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Summary of Product Characteristics last updated on medicines.ie: 8/10/2018

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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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
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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
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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 8 October 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 8 October 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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: Change to section 4.8 – Undesirable effects – how to report a side effect
IE: Editorial change to underline website and email addresses

SPC: Change to section 6.5 – Nature and contents of container
Removed details regarding vials and the subheading regarding prefilled syringe.

SPC: Change to section 8 – Marketing authorisation number(s)
Removed the MA numbers for the Vial presentation and the subheading regarding prefilled syringe.

Updated on 24 November 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 24 November 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.8 - Undesirable effects
  • 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 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company



Section 6.6 Special precautions for disposal and other handling - Revised to improve the instructions regarding re-suspension of the vaccine following storage.
Section 4.8 Undesirable effects - Creation of a new System Organ Class for Post-marketing surveillance adverse reaction ‘General disorders and administration site conditions’, with the adverse reaction ‘Immediate injection site pain’ moved from its previous class of ‘Nervous system disorders’
Section 1 Name of the medicinal product - Removal of the dosage form ‘pre-filled syringe’ from the product name
Section 6.5 Nature and contents of container - description of vials added
Section 8 - MA numbers for vials added
Improved presentation of SPC - Minor editorial updates to SPC Sections 3, 4.2, 4.3, 4.5, 4.8 and 10

      

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 23 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 November 2016 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 23 November 2015 PIL

Reasons for updating

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

Updated on 2 March 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Improved electronic presentation

Updated on 2 March 2015 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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 2: Minor format update (QRD)  and an update to include neomycin being used in the manufacturing process

 

Section 4: Minor typo update

 

Section 4.7: Minor QRD format update

 

Section 4.8: Minor QRD format update,  an update to the frequency of commonly reported adverse reactions and  an update to the adverse reporting section.

 

Section 5.3: Minor QRD format

 

Section 6.6:  Minor QRD format

 

Section 10: Update to revision date

Updated on 15 March 2012 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

Change to:

Section 4.4 - Special warnings and precautions for use,
Section 4.8 - Undesirable effects

Updated on 14 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 21 October 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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

4.2       Posology and method of administration

In the ‘Posology’ section, under the subheading ‘Booster dose’, updated the statement regaring the availability of long term persistence data following vaccination of up to 15 years (previously 60 months).

 

4.6       Fertility, pregnancy and lactation

Updated the heading to include ‘Fertility’

 

5.1       Pharmacodynamic properties

Updated the statement regarding two long term clinical studies conducted in adults aged 17 years to 43 years to read to reflect data for 15 years as opposed to the previous data for 60 months, to read:

In two long term clinical studies conducted in adults aged 17 years to 43 years, 56 subjects had evaluable tests 15 years after the primary vaccination with Twinrix Adult; the anti-HAV seropositivity rates were 100% in both studies and the anti-HBs seroprotection rates were 89.3% and 92.9%, respectively. The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.

 

6.6       Special precautions for disposal and other handling

Updated wording regarding the description of physical appearance of the vaccine on visual inspection prior to administration, from ‘variation in physical aspect’ to ‘abnormal physical appearance’

Updated on 31 May 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 20 April 2010 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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 Undesirable effects

Under the subheading ‘Clinical trials’, deleted the following paragraph referring to the thiomersal-free formulation:

The current formulation of Twinrix does not contain thiomersal (an organomercuric compound) or any preservative. In a clinical study conducted with the current formulation, the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed with the former thiomersal and preservative containing vaccine formulation. The following undesirable effects have been reported following the widespread use of the former formulation.

 

 

 

Section 5.1 Pharmacodynamic properties

 

1.         Updated following the results of clinical studies HAB 163 and 168, i.e., the following annotations:

In a clinical study conducted in subjects over 40 years of age, the seropositivity rate for anti-HAV antibodies and seroprotection rate against hepatitis B of Twinrix Adult following a 0, 1, 6 months schedule were compared with the seropositivity and seroprotection rates of monovalent hepatitis A and B vaccines when  administered in opposite arms.

The seroprotection rate against hepatitis B after the administration of Twinrix Adult was 92% and 87.556% at 7 and 12 48 months respectively, versus 80% and 7443% after the GlaxoSmithKline Biologicals monovalent 20µg hepatitis B vaccine, and 71% and 5631% after another licensed monovalent 10µg hepatitis B vaccine. However, aAnti-HBs antibody concentrations decreased as age and body mass index increased; they were also lower in male than in female subjects.

The seropositivity rate for anti-HAV antibodies after Twinrix Adult was 97% and 96% at both 7 and 12 48 months respectively versus 99% and 9893% after the GlaxoSmithKline Biologicals monovalent hepatitis A vaccine and 99% and 97%at both 7 and 12 months after another licensed monovalent hepatitis A vaccine.

Subjects received an additional dose of the same vaccine(s) 48 months after the first dose of the primary vaccination course. One month after this dose, 95% of the subjects vaccinated with Twinrix Adult achieved seroprotective levels of anti-HBV antibodies (≥ 10 mIU/ml) and Geometric Mean Concentrations (GMC) increased by 179-fold (GMC of 7234 mIU/ml) indicative of an immune memory response.

 

In two long term clinical studies conducted in adults aged 17 years to 43 years, persistence of anti-HAV and anti-HBs antibodies has been proven up to 60 months following the initiation of a primary vaccination course of Twinrix Adult in the majority of vaccinees.  The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.

 

2.         Deleted the following paragraph regarding the formulation containing thiomersal:

These data were generated with the former Twinrix formulation containing thiomersal and a preservative. A clinical study conducted with the current formulation of Twinrix in adults showed that the current formulation elicited similar seroprotection and seroconversion rates as compared to the former formulation.

 

Updated on 14 April 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 5 September 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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

 

4.4 Special Warnings and Precautions: Reference to Thiomersal removed, Warning regarding effect of obesity on the immune response

4.8 Undesirable effects: Revision of undesirable effects and categorisation by frequency

4.9 Overdosage: Rewording regarding cases reported during post-marketing surveillance

4.6 Pregnancy and Lactation: Clarification of use in pregnancy

5.3 Pre-clinical safety: Reference included to section 4.6

6.1 Excipients: Phenoxyethanol removed

Updated on 29 August 2008 PIL

Reasons for updating

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

Updated on 15 March 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 27 February 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 30 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 August 2004 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)

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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