Boostrix - Suspension for injection

  • Name:

    Boostrix - Suspension for injection

  • Company:
    info
  • Active Ingredients:

    Diphtheria, Tetanus and Pertussis 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: 19/01/17

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Summary of Product Characteristics last updated on medicines.ie: 21/6/2019

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

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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 21 June 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.5 updated with data on the co-administration with Meningococcal serogroup A, C, W and Y conjugate vaccines.

Section 4.8 and 5.1: Editorial changes to add table number.

 

 

Updated on 5 February 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Change to section 4.6 – Fertility, pregnancy and lactation
Added the statement 'For data relating to the prevention of pertussis disease in infants born to women vaccinated during pregnancy, see section 5.1', and moved the statement 'The use of Boostrix may be considered during the third trimester of pregnancy' to the start of the 'Pregnancy' subsection.
 

Updated on 9 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2017 SmPC

Reasons for updating

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

Change to section 5.1 – Pharmacodynamic properties
Under the subheading 'Immune response in subjects without prior or with unknown vaccination history', the number of subjects (adolescents aged from 11 to 18 years) described as having received Boostrix was reduced from 123 to 83. As a consequence, the sensitivity of the analysis changed, resulting in the revision of the range of variability of the seropositivity rate for the different pertussis antigens after one dose, changed from between 90% and 98% to 87% and 100%.

Change to section 4.8 – Undesirable effects
Under 'Clinical trials', added the subheading 'Reactogenicity after repeat dose' and moved the corresponding text from its previous position under 'Post marketing surveillance' to under the new subheading.

Updated on 20 January 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • 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

Change to section 4.1 Therapeutic indications

·         Deleted the statement ‘Boostrix is not intended for primary immunisation’

·                Added the statement ‘The administration of Boostrix should be based on official recommendations’

 

Change to section 4.2 – Posology and method of administration

Posology

·                Added the statement: ‘The use of Boostrix may be considered during the third trimester of pregnancy. For the use of the vaccine before the third trimester of pregnancy, see section 4.6’

·                Revised the description of the antigen content of diphtheria, tetanus and pertussis from ‘low adult dose’ to ‘reduced content’

·                Replaced the statements regarding vaccination of adults with the following: ‘Boostrix may be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation series against diphtheria, tetanus and pertussis. Based on data in adults, two additional doses of a diphtheria and tetanus containing vaccine are recommended one and six months after the first dose to maximize the vaccine response against diphtheria and tetanus (see section 5.1)’

 

Change to section 4.3 – Contraindications

·                Revised the spelling of ‘contraindicated’ and ‘contraindication’ (removed hyphenation)

 

Change to section 4.4 – Special warnings and precautions for use

·                Revised the spelling of ‘contraindication’ (removed hyphenation)

 

Change to section 4.6 – Pregnancy and lactation

·                Reorganised the order of the text along the sequence of ‘Pregnancy’, Breastfeeding’ and ‘Fertility’

·                Under the subheading ‘Pregnancy’, replaced the existing statements (lack of data for use in pregnancy, risk based use of vaccine in pregnancy and no expected harm to the foetus), with the following:

o    Safety data from a prospective observational study where Boostrix was administered to pregnant women during the third trimester (793 pregnancy outcomes) as well as data from passive surveillance where pregnant women were exposed to Boostrix or to IPV-Boostrix (dTpa-IPV vaccine) in the 3rd and 2nd trimester have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child.

o    The use of Boostrix may be considered during the third trimester of pregnancy.

o    Human data from prospective clinical studies on the use of Boostrix during the first and second trimester of pregnancy are not available. However, as with other inactivated vaccines, it is not expected that vaccination with Boostrix harms the foetus at any trimester of pregnancy. The benefits versus the risks of administering Boostrix during pregnancy should be carefully evaluated.

 

Change to section 4.8 – Undesirable effects

·                Formatting and typographical updates to align with the current formatting requirements of the QRD Template, including the tabulation of adverse reactions.

 

Change to section 5.1 – Pharmacodynamic properties

·                Added the following subheading and statement regarding the immune response in subjects without prior or with unknown vaccination history:

Immune response in subjects without prior or with unknown vaccination history

After administration of one dose of Boostrix to 123 adolescents aged from 11 to 18 years, without previous pertussis vaccination and no vaccination against diphtheria and tetanus in the previous 5 years, all subjects were seroprotected against tetanus and diphtheria. The seropositivity rate after one dose varied between 90% and 98% for the different pertussis antigens.

·         Formatting update, to include the following subheadings:

Immune response

Persistence of the immune response

Efficacy in protecting against pertussis

Immune response after a repeat dose of Boostrix

Immune response in subjects without prior or with unknown vaccination history

Updated on 19 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 January 2017 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
  • Improved presentation of PIL

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

 

Updated on 16 July 2015 PIL

Reasons for updating

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

Updated on 30 June 2015 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 – IMB name change to HPRA

Section 10 – Date update

Updated on 30 June 2015 PIL

Reasons for updating

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

Updated on 14 July 2014 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

4.6          Fertility, pregnancy and lactation:

‘Fertility’ and ‘Pregnancy’ sections updated with data from animal studies regarding reproductive toxicity, while confirming that data in humans are not available and therefore the warning remains unchanged, i.e. that the vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus.

 

4.8        Undesirable effects

Under ‘Post-marketing surveillance’, moved ‘angiodema’ from ‘blood and lymphatic disorders’ to ‘skin and subcutaneous tissue disorders’

Added the instructions regarding the reporting of adverse events to the Pharmacovigilance section of the  IMB.

 

5.3        Preclinical safety data

Added the subheading ‘Reproductive toxicology’ with the additional statements regarding fertility and pregnancy.

Updated on 11 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 11 January 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 4.9 - Overdose
  • 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

Chage to Section 2,  4.2,  4.3,  4.4,  4.4,  4.5,  4.6,  4.8,  4.9 & 5.1

Updated on 11 January 2012 PIL

Reasons for updating

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

Updated on 14 April 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Under the subheading ‘posology’, added pertussis to the following sentence:

Repeat vaccination against diphtheria, tetanus and pertussis should be performed at intervals as per official recommendations (generally 10 years).

 

4.8       Undesirable effects

Under the subheading ‘For adults and adolescents from the age of 10 years onwards (N = 1,515)’/’Clinical trials’/’Skin and subcutaneous tissue disorders’:

Corrected the spelling for pruritus

 

Under the subheading ‘Post-marketing surveillance’

Added the statement:

Data suggest that in subjects primed with DTP in childhood a booster dose might give an increase of local reactogenicity.

 

5.1       Pharmacodynamic properties

Added data on seroprotection / seropositivity rates for 10 years following first vaccination with Boostrix

 

Added the following statement:

The immunogenicity of Boostrix, administered 10 years after a previous booster dose with reduced-antigen content diphtheria, tetanus and acellular pertussis vaccine(s) has been evaluated. One month post vaccination, > 99 % of  subjects were seroprotected against diphtheria and tetanus and seropositive against pertussis.

 

Updated on 13 August 2010 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 2 June 2010 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • 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

As a result of V025, the following statement was deleted:

Individuals with an incomplete, or no, history of a primary series of diphtheria and tetanus toxoids should not be vaccinated with Boostrix.  Boostrix is not precluded in subjects with an incomplete, or no, history of previous pertussis vaccination.  However a booster response will only be elicited in individuals who have been previously primed by vaccination or by natural infection.

 

and replaced with:

In subjects ³ 40 years of age that had not received any diphtheria or tetanus containing vaccine in the past 20 years, one dose of Boostrix induces an antibody response against pertussis and protects against tetanus and diphtheria in the majority of cases. Two additional doses of a diphtheria and tetanus containing vaccine will maximize the vaccine response against diphtheria and tetanus when administered one and six months after the first dose (See section 5.1)

As a result of V025, the following statement was deleted:

There are no data on the duration of protection against pertussis following vaccination with Boostrix.

 

4.4       Special warnings and precautions for use

As a result of the Renewal, deleted reference to vaccination in infants in the following statement:

As for any vaccination, the risk-benefit of immunising with Boostrix or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.

 

4.5       Interaction with other medicinal products and other forms of interaction

As a result of the Renewal, updated the statement regarding concomitant administration to the following:

Concomitant administration of Boostrix with other vaccines or with immunoglobulin has not been studied.  It is unlikely that co-administration will result in interference with the immune responses. According to generally accepted vaccine practices and recommendations, if concomitant administration of Boostrix with other vaccines or immunoglobulin is considered necessary, the products should be given at separate sites.

 

4.8       Undesirable effects

As a result of V025, added statement regarding local reactogenicity (previously not evaluated):

Data on 146 subjects suggest that there might be a small increase in local reactogenicity (pain, redness, swelling) with repeated vaccination according to a 0, 1, 6 months schedule in adults (> 40 years of age).

 

5.1       Pharmacodynamic properties

As a result of the Renewal, regarding the one month post vaccination immune responses, added clarification that the vaccine response to pertussis toxoid was

defined as ³ 5 EL.U/ml antibody in subjects who were seronegative prior to boosting or at least two-fold increase in antibody concentrations in subjects who were seropositive prior to boosting.

 

As a result of the V024, updated the data on seroprotection/seropositivity rates to include results from 5 and 6 years following vaccination (in addition to the data in previous version of the SPC for 3.5 years):

Antigen

Seroprotection/

seropositivity

Adults and adolescents from the age of 10 years onwards

(% vaccinees)

Children from the age of 4 years onwards

(% vaccinees)

3-3.5 years persistence

5 years persistence

3-3.5 years persistence

5-6 years persistence

Diphtheria

³ 0.1 IU/ml

71.2-91.6 %

84.1-86.8 %

97.5 %

94.2 %

 

³ 0.016 IU/ml*

97.4-100 %

94.4-99.2 %

100 %

Not determined

Tetanus

³ 0.1 IU/ml

94.8-100 %

96.2-100 %

98.4 %

98.5 %

Pertussis

  Pertussis toxoid

  Filamentous haemagglutinin

  Pertactin

 

 

³ 5 EL.U/ml

 

81.6-90.6 %

100%

 

94.8-99.2 %

 

76.8-89.5%

100%

 

95.0-98.1%

 

58.7 %

100 %

 

99.2 %

 

51.5 %

100 %

 

100 %

* Percentage of subjects with antibody concentrations associated with protection against disease (³ 0.1 IU/ml by ELISA assay or ³ 0.016 IU/ml by an in-vitro Vero-cell neutralisation assay).

 

As a result of the V025, added statement regarding immunogenicity (previously not evaluated):

After administration of one dose of Boostrix to 139 adults ³ 40 years of age that had not received any diphtheria and tetanus containing vaccine in the past 20 years, more than 98.5% of adults were seropositive for all three pertussis antigens and 81.5% and 93.4% were seroprotected against diphtheria and tetanus respectively. After administration of two additional doses one and six months after the first dose, the seropositivity rate was 100% for all three pertussis antigens and the seroprotection rates for diphtheria and tetanus reached 99.3% and 100% respectively.

 

6.1       List of excipients

Deleted Phenoxyethanol

 

6.6       Special precautions for disposal and other handling

As a result of the Renewal, added statements that vaccine should be at room temperature prior to use and that any unused product or waste material should be disposed of in accordance with local requirements.

 

 

 

Updated on 3 December 2008 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

 

Inclusion of the following statement in section 4.4 regarding neurological disorders: 'As for any vaccination, the risk-benefit of immunising with Boostrix or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.'

Updated on 25 November 2008 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 4.2 - 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 6.1 - 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)

Free text change information supplied by the pharmaceutical company

Summary of changes to SPC:

#1 Name and INN updated

#2 Quantification of aluminium hydroxide, hydrated and aluminium phosphate.

#3 Description updated to include 'pre-filled syringe' and to include physical description.

#4.2 Removal of reference to toxoids and to include preference to administration in the deltoid region.

#4.3 Rewording of statements regarding hypersensitivity and regarding neurological complications.

#4.4 Removal of requirement for a clinical examination. and minor editiorial changes.

#4.5 Removal of term 'inactivated' when referring to 'other vaccines'. Removal of reference to patients with immunodeficiency.

#4.6 Rewording of statements regarding use while breastfeeding to clarify that no risk expected but benifit/risk should be evaluated by health-care provider.

#4.8 Rewording and re-ordreing under Clinical data and post-marketing data; no new side effects.

#5.1 Added 'pertussis' in pharmacotherapeutic properties.

#6.1 Removed formaldehyde, polysorbate 80 and glycine, added reference to 'adjuvants'.

#6.4 Added instruction re storage to protect from light.

#6.6 Heading updated.

Updated on 19 November 2008 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions
  • Change to further information section
  • Change to appearance of the medicine

Updated on 17 July 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 17 July 2008 PIL

Reasons for updating

  • New PIL for medicines.ie