Menveo, powder and solution for solution for injection

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/06/19

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Summary of Product Characteristics last updated on medicines.ie: 5/6/2019

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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
Medicine Name Babyhaler Active Ingredients No Active Ingredients
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 June 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 5 June 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

sec 4.5 - to include reference to concomitant administration with Meningococcal group B vaccine

Updated on 26 March 2019 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Update to section 6.5 to the material of the container for the vial presentation

Updated on 31 January 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 31 January 2019 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 25 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 November 2016 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 9 October 2015 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 October 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 name of marketing authorisation holder

Updated on 8 October 2015 PIL

Reasons for updating

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

Updated on 29 July 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • 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

Reasons for adding or updating:

·         Change to section 4.4 - Special warnings and precautions for use

·         Change to section 4.8 - Undesirable effects

·         Change to section 5.2 - Pharmacokinetic properties

·         Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC: 26-Mar-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update of the Section 4.8 “Undesirable effects” of the SmPC:

update of the overall exposure for children aged ≥2 years who have received the vaccine in completed clinical trials.

Update of the Section 4.4 “Special warnings and precautions for use” of the SmPC + Package Leaflet: inclusion of a warning on anxiety-related reactions as per Menveo CDS v4.3.


Addition of Renewal date into sec. 9 of the SmPC

New persistency data for children 2-10.
Existing persistency data for adolescents corrected.

Updated on 27 July 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 15 October 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to drug interactions
  • Change to appearance of the medicine
  • Removal of black triangle

Updated on 15 October 2014 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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
  • 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

4.2

Section: Posology

·         term elderly removed

·         Optimal primary dosing schedule included

 

Section : Booster vaccination

·         updated re Imunogenicity /Long term antibody persistence data for 5 yrs included

·         Booster dosing

4.4

Section : Special warnings and precautions

·         Consideration re booster dosing

4.5

Section : Interaction with other medicinal products and other forms of interaction

·    Concomitant vaccine advice and usage updated

·    Update advice on concomitant vaccine injection sites

4.8                           

Section: Adverse reactions from clinical trials

·         Updated on the characterisation of  safety profile of Menveo in children 2-10 years

Section: Individuals 11 to 65 years of age

·         Updated trial data and increase in trial numbers, change to results

·         In list of adverse reactions from clinical trials, removal side effects  text re: immune system disorders ,  hypersensitivity, syncope, vertigo

Section: General disorders and administration site conditions

·         Editing and inclusion of text

·         Removal of spontaneous reporting text

Section: Post marketing experience ( all age groups)

·         Updated text sections and changes to read ‘not known’

Section : Reporting of suspected adverse reactions

Inclusion of text : Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Pharmacovigilance Section at the Irish Medicines Board at www.imb.ie.

 

5.1

 

Section: Pharmacodynamic properties

Immunogenicity

·         Amended- immunogenicity in children from 2, to 2 to 10 years of age

·         Tables and data up dated re trials- tables renumbered

·         Previous Table 4-21 month post vaccination text and data removed

·         Inclusion of text re: Persistence of immune response and booster response in adolescents, before table 5

·         Text on booster dose study results included

·         After renumbered table 8, text included re the onset of the immune response after primary vaccination

6.5

Section: Nature and contents of container

·         Removal of text re contents of components( now in 6.6)

6.6

Section: Special precautions for disposal and other handling

·         Inclusion of text re mixing vials

·         Inclusion of text (metric replaces non metric) re needle length

10

Section: Date of revision of text

·         18/06/2014

·         UK/MEN/14-0012 

Updated on 14 August 2013 SmPC

Reasons for updating

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

Paediatric population (under 2 years of age)



Section 5.1

Available data in children 2 to 23 months of age

Updated on 1 February 2013 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 31 July 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 addition

Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1). The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown. Currently there is limited information available on the safety of a booster dose. However, if an individual is expected to be at particular risk of exposure to Men A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose.

Section 4.8 additions from post marketing spontaneous reports

Updated on 21 March 2012 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided