Twinrix Paediatric, suspension for injection
- Name:
Twinrix Paediatric, suspension for injection
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
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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 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 - how to report a side effect
- 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 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 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
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 31 May 2011 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to dosage and administration
Updated on 24 February 2011 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to dosage and administration
Updated on 27 January 2011 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
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
Regarding the Posology of a Booster dose, updated wording from:
Long-term antibody persistence data following vaccination with Twinrix Paediatric are available up to 48 months after vaccination.
to:
In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given. The safety and immunogenicity of Twinrix Paediatric administered as a booster dose following a three dose primary course have not been evaluated.
Deleted the statement:
The kinetics of antibody decline are also similar.
Deleted the statement:
anti-HAV antibodies have been predicted to persist for at least 10 years.
4.5 Interaction with other medicinal products and other forms of interaction
Added the following statement:
Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A 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 ³ 10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Updated the statement regarding concommitanmt administration with other vaccines to read:
Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically studied. It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric.
4.6 Fertility, pregnancy and lactation
· Updated heading to include ‘Fertility’
· Changed subheading from ‘lactation’ to ‘breastfeeding’
4.8 Undesirable effects
Deleted the following statement regarding thiomersal:
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 events have been reported following the widespread use of the former formulation.
5.1 Pharmacodynamic properties
Updated the statements on persistence of anti-HAV and anti-HBs antibodies, further to the results of two clinical trials, to read:
In two long term clinical trials, persistence of anti-HAV and anti-HBs antibodies has been demonstrated up to 10 years in children aged 12-15 years and up to 5 years in children aged 1-11 years.
At 10 years following the initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged 12-15 years, all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 85% had anti-HBs antibody ≥10 mIU/ml.
At 5 years following initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged 1-11 years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 97% had anti-HBs antibody ≥10 mIU/ml.
The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Deleted the following statement regarding 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 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, 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 16 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 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)